Brief Title
A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus
Official Title
A Phase 2 Feasibility Study of Abraxane and Carboplatin in Epithelial Neoplasms of the Uterus
Brief Summary
The purpose of this study is to evaluate the safety of treatment with carboplatin and
Abraxane in this patient population and determine the nature and degree of toxicities
following treatment. The single stage open label Phase II feasibility study is designed to
estimate the proportion of patients who can tolerate the proposed regimen for 6 cycles with
no more than two dose level reductions.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Tolerability Measured Completion of Dose Regimen
Secondary Outcome
Survival
Condition
Endometrial Cancer
Intervention
Carboplatin AUC
Study Arms / Comparison Groups
Carboplatin AUC and Abraxane 100mg/m2
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
23
Start Date
July 2016
Completion Date
March 2020
Primary Completion Date
August 17, 2018
Eligibility Criteria
Inclusion Criteria:
- Female patients must have high risk resected stage I disease (papillary serous
histology, clear cell histology or carcinosarcoma), advanced stage (III or IV, all
histologies) or recurrent endometrial cancer (all histologies). Patients do not need
measurable disease and can enroll following surgery.
- Patients may not have received prior cytotoxic chemotherapy. However,
nonplatinum/non-taxane chemotherapy used for radiation sensitization is allowed.
Patients may have received prior radiation therapy (including whole pelvic or vaginal
brachytherapy), hormonal therapy, or therapy with biologic agents, but such therapy
must be discontinued at least 2 weeks prior to entry on this study.
- If patients underwent surgery, and chemotherapy is indicated after surgery either as
adjuvant or to treat residual disease, study treatment should be initiated within 8
weeks of surgery.
- In patients who have received prior radiation, at least 4 weeks should have elapsed
since the completion of radiation therapy involving the whole pelvis or over 50% of
the spine. If vaginal brachytherapy is planned with chemotherapy, it should be done
before or after completion of chemotherapy treatment.
- Poorly differentiated histology, uterine papillary serous carcinoma, clear cell
carcinoma or carcinosarcoma is acceptable as long as the predominant metastatic
component is epithelial (versus sarcomatous).
- Patients may have synchronous endometrial and ovarian cancer primaries.
- Patients must have a GOG performance status of 0, 1, or 2
- Patients must be at least 18 years of age.
- Patients must understand and willingly sign an approved informed consent, and
authorization permitting release of personal health information.
- Patients must have adequate liver function: AST and ALT ≤ 2.5 X upper limit of normal
(ULN), and bilirubin ≤ 1.5mg/dL.
- Patients must have adequate bone marrow function: platelets ≥ 100,000 cells/mm3
(transfusion independent, defined as not receiving platelet transfusions within 7 days
prior to laboratory sample), hemoglobin > 9.0g/dl and ANC ≥ 1,500 cells/mm3.
- Patients must have adequate renal function: creatinine < 1.5 mg/dL is recommended;
however, institutional norms are acceptable.
- Patients must have < grade 2 pre-existing peripheral neuropathy (per CTCAE).
Exclusion Criteria:
- Other prior malignancies within 3 years, except non-melanoma skin cancers and
synchronous ovarian primaries.
- Eligibility to a higher priority trial for first line or recurrent endometrial cancer
(unless patient is unwilling to participate in such a trial).
- Patients with concomitant medical illness such as serious uncontrolled infection, or
uncontrolled angina, which in the opinion of the treating physician, make the
treatments prescribed on this study unreasonably hazardous for the patient.
- Patients who are pregnant or breastfeeding.
- Patients with third degree or complete heart block are not eligible unless a pacemaker
is in place. Patients on medications, which alter cardiac conduction, such as
digitalis, beta-blockers, or calcium channel blockers, or who have other conduction
abnormalities or cardiac dysfunction could be entered at the discretion of the
investigators.
- Patients with history of myocardial infarct within 6 months before enrollment, New
York Heart Association (NYHA) class II or greater heart failure or symptoms suspicious
for congestive heart failure are not eligible unless a LVEF in the past 6 months is
documented to be 50% or greater. Patients who have had a LVEF (performed for any
reason) that is less than 50% in the past 6 months are ineligible.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Franco Muggia, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02744898
Organization ID
15-01156
Responsible Party
Sponsor
Study Sponsor
NYU Langone Health
Study Sponsor
Franco Muggia, MD, Principal Investigator, NYU Langone Health
Verification Date
March 2020